Tactics for Global Pivotal Studies – MedTech CRO: Clinical Trial Execution Series

Device Advice by RQM+

*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please ⁠⁠⁠reach out to RQM+⁠⁠⁠ if you need support with clinical trials.*

🌍 Our educational video series on clinical trials continues today with 𝗧𝗮𝗰𝘁𝗶𝗰𝘀 𝗳𝗼𝗿 𝗚𝗹𝗼𝗯𝗮𝗹 𝗣𝗶𝘃𝗼𝘁𝗮𝗹 𝗦𝘁𝘂𝗱𝗶𝗲𝘀.

Senior Project Manager Guido Rieger joins VP of Global Regulatory Affairs, Jaishankar Kutty, Ph.D. to outline:

📋 𝗦𝘁𝗲𝗽𝘀 𝘁𝗼 𝗘𝘅𝗲𝗰𝘂𝘁𝗲 𝗮 𝗣𝗶𝘃𝗼𝘁𝗮𝗹 𝗧𝗿𝗶𝗮𝗹:

– Identifying key stakeholders

– Defining study endpoints and scope

– Budgeting and regulatory planning

🛠️ 𝗣𝗹𝗮𝗻𝗻𝗶𝗻𝗴 𝗮𝗻𝗱 𝗘𝘅𝗲𝗰𝘂𝘁𝗶𝗼𝗻:

– Study protocol development

– Regulatory submissions and ethics approvals

– Site and patient selection

🔍 𝗡𝗮𝘃𝗶𝗴𝗮𝘁𝗶𝗻𝗴 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗡𝘂𝗮𝗻𝗰𝗲𝘀:

– Understanding local regulations

– Importance of local expertise

🚀 𝗖𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 𝗮𝗻𝗱 𝗦𝗼𝗹𝘂𝘁𝗶𝗼𝗻𝘀:

– Addressing patient recruitment issues

– Site selection and vendor coordination

– Risk management strategies

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